Q1 2021 Infinity Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the Infinity Pharmaceuticals conference call to discuss the company's operations and first quarter and it's why did come under one financial results. My name is now and I will be your operator for today's call. At this time all participants are in a listen only mode.
There will be a question and answer session to follow please.
We advise that this call is being recorded and did it used to request now I would like to introduce your host for today's call Jayne Kauffman Ma'am. Please go ahead.
Thank you Mel and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our first quarter 2021 financial results on the call with me today are idling and Perkins, Chief Executive Officer, Larry Bloch, President and Brian Swartz consulting Chief position, we'll open the call for Q&A.
And following our remarks the press release issued this afternoon day.
Details of our results and is available on our website at <unk> Dot Com. Please note that during this call. We may make forward looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections and our actual results may do.
Differ materially from what we project today due to a number of important factors, including the considerations described and the risk factors section of our annual report on form 10-K for 'twenty, and 'twenty and and other filings we make with the SEC.
These forward looking statements may represent our views only as of today and we caution you that we may not update them and the future whether as a result of new information future events or otherwise now I'd like to turn the call over to Abilene.
Yeah.
Thanks, Jim and thank you everyone for joining us today.
We've reached and an exciting inflection point at Infinity, having January and compelling data, which demonstrate the broad potential and again I'll, let them to improve them.
Treatment regimen and.
And multiple solid tumors.
We're poised to build on this momentum with a substantial take this summer and triple negative breast cancer data presented at the San Antonio breast cancer Symposium with day that on it and it's twice as many patients. In addition to providing an update on our future plans and your cancer and.
And corporate event on Tuesday July 27.
Over the last six months and generating important clinical Readouts primary and one Mary are free.
Two and Marriott 275 studies.
Different indications, which have led to broad and potential of the analysts and unique macrophage targeting immune modulating mechanisms.
And with them.
Our preclinical and translational and clinical data.
And really shown that analysts and has the potential to create a T cell inflamed tumor microenvironment from a non T cell and claims environment, sometimes simplified and turning cold tumors Hot.
Activating and immune response and increase and PDL, one expression, the crime and four and increasing the effectiveness of checkpoint inhibitors, regardless of baseline PD L. One level.
On today's call are consulting cheap position and Dr. Brian Schwartz will discuss net that car T and D C and UC program, but before that I'd like to briefly remind you of the data we've presented over the last six months and chronological order and program guidance.
First data from Mario one our phase <unk> study in collaboration with Bristol Myers Squibb evaluating with analysts and in combination with Opdivo and patients with advanced solid tumors, namely melanoma and squamous cell cancer of the head net what presented at 50 and November 2020. These.
These data reinforce the potential of the analyst day.
Become resistant to checkpoint inhibition, including in patients who progressed on a checkpoint inhibitor as their immediate prior therapy.
Second.
Data from the T N P C cohort of Mario three our phase II study in collaboration with Roche Genentech, and which we are evaluating the combination of the analysts and with to centric and Nebraska as a frontline treatments and patients with can be C were presented at San Antonio breast and December 2020. These.
These data show a highly encouraging inquiry and the overall response rate and disease control rate irrespective of baseline PD one status.
With the addition of a gamma listen to the to centric and attracting standard of care doublet, which received accelerated approval for the treatment of PD, one high but not to go and frontline T&D and patient.
Third data from the ARCUS collaboration a phase <unk> study evaluating a analyst day and a novel checkpoint inhibitor free regimen that includes a trim and Dennis their dual adenosine receptor and cabinets and docile and patients with relapsed refractory triple negative breast cancer and ovarian cancer.
Were also presented at San Antonio Breast and December.
And show an increase and response rate with the addition of the analysts and novel doublet therapy, both indications.
And most recently and the first quarter of 2021, we presented data and <unk> primary up to 75 are randomized double blind placebo controlled phase II study in collaboration with BMS.
Uhm analysts and in combination with Opdivo and patients with advanced and your filial cancer.
These data show improvements and response rate disease control rate and progression free survival, particularly in patients with low levels of PD lone expression, who are known to not respond well to checkpoint inhibitor.
Alone and suggest the addition of the Gantlet types of standard of care Opdivo monotherapy can improve patient outcomes.
Our strong execution and steady progress has propelled us analysts and forward with signals of activity across the diverse settings, including double and triple combination and the first second and third line and also across multiple solid tumors, which Brian will review in more detail.
These day to lead us.
And with confidence and the potential of a gander list and to improve responses in patients with some of the greatest unmet needs and oncology.
Moving to our high level thoughts regarding future development opportunity for Gander list them.
And frontline T and B C passport and combination with central to Nebraska, and will be a function of our mature and data, which we will be presenting on July 27, and again and the fourth quarter of 2021.
We plan to cut the data as close to the end of the first half of 2021 as possible.
And robust data set possible this summer.
Additional data will be presented and the fourth quarter of this year and completion of enrollment is on track for the second half of the year.
Our current plan plan and bladder cancer and stuff.
Focus on the PD, one low population, who represent the majority of second line bladder cancer patients and also the patients with the greatest unmet need.
Checkpoint inhibitors and provide a little to no benefit in these patients with some approvals being limited to the PD one high patient population.
And with Keytruda, and just centric and frontline Europe Yale cancer.
While our day to suggest gamma lists and could be a benefit to all patients regardless of PD. One status. We plan to initially focus on tier one locations given the magnitude of Nogales the benefit seen in these patients over upheaval monotherapy such that it should be possible to demonstrate the benefit of adding again analyst.
And you go and a relatively smaller number of patients, enabling smaller registration trial, which can therefore be faster and less expensive.
Duck.
2021 quite meet your meaningful data update.
Execution, and our strong balance sheet from the $92 million public offering and Q1 leaves us well positioned to continue executing on the development of a gamma listen to demonstrate the potential of our first in class and wholly owned message targeting therapeutics with that I'll turn the call over to Brian.
Thank you Leanne and.
And he mentioned are encouraging initial data from Mario three and frontline triple negative breast cancer showed a patient benefit from the addition of again and listen to and approved standard of care regimen. In this case, the Roche Genentech regimen after century can and brick, saying and frontline <unk>.
C, which received accelerated approval for use in PD one positive patients.
San Antonio Breast Conference last September last December we presented efficacy data from the first 13, evaluable patients as well as safety data on 20 patients and.
<unk> seven patients who enrolled but have not received their first efficacy scanner we.
We were thrilled to reported 100 per cent of the Evaluable patients and a reduction in tumor volume regardless of the PDL one status with 69% had either a partial or complete response with 100% and the PD Lone high patients.
Funding and 50% on the PD lone low patients responding.
This study has been progressing really well and we look forward to reporting data on approximately twice as many patients as well as initial look at durability of responses on July 27.
The accelerated approval of <unk> centric and a break sane and PDL, one high frontline triple negative breast cancer patients and subject to confirmation and some subsequent studies was the subject of a recent FDA oncology drug Advisory Committee or <unk> review, which highlighted.
The need for better treatment for these triple negative breast cancer patients.
In addition, there is also clearly a need for the PD, one low patients for which checkpoint inhibitors have not been approved.
Our initial Mario three data suggests that the upregulation of PD L. One with each analyst treatment could improve the effectiveness of checkpoint inhibitors and triple negative breast cancer, regardless of baseline PD lone status such that we see multiple paths forward.
As a maturing data will be and instrumental and prioritizing the focus the future clinical development.
And particularly in particular, we will assess whether the addition of began Elisa provides a greater benefit to PD lone low patients PD lone high patients all patients regardless of the PDL, one status and designing follow one registration focused studies.
In Q1, we presented data from Mario 275.
Randomized placebo controlled phase II study evaluating the efficacy and safety of began Elisa and combination with Opdivo in second line platinum refractory Io naive patients with your residual cancer.
The results presented at Ash and <unk> showed the combination I'll begin Elisa with Opdivo and improve the overall response rate disease control rate and the progression free survival versus.
So sick and line standard of care Opdivo monotherapy.
In all patients regardless of PD, one expression levels.
However, the greatest benefit over Opdivo monotherapy was observed in the PD lone low patients, bringing the overall and D. C are two equal levels or above the responses and disease control rates seen in the PD Lone high patients by BMS and the approval study for <unk> T.
<unk> monotherapy.
Study was called Checkmate 275.
We were also encouraged by the PFS hazard ratio of <unk> five full such that patients receive combination treatment with 46% like less likely to progress.
Relative to patients on the Opdivo plus placebo arm.
And any indication of significant patient benefit.
We believe these results demonstrate that again relative as a potential to raise the level of benefit and PD lone low patients to a level equivalent that observed with the standard.
And I O therapy, and PD lone high patients as well as increasing the benefit for PDL, one and high patients.
Based on these results we are plant and the planning stages of a registration trial and we look forward to providing details of our progress and bladder cancer based on our interactions with regulatory authorities and and the context of the recent OPEC meeting and.
Accelerated approvals for Keytruda and to centric and frontline bladder cancer were reviewed.
Leveraging the strong data from Mario 275, and the initial feedback from the FDA, we expect to provide and update on <unk> and Elisa and PD L. One low bladder cancer patients on July 27.
Lastly, moving to our renal cell cohorts and Mario three our guidance remains unchanged and we expect to report data in the first half of 2022 from our ongoing fully enroll proof of concept novel Triple combination all day.
And again listen to centric and then Brent and vested and frontline renal cell carcinoma.
[noise] 2021 is going to be a transformative year for infinity.
The key data readout and the emerging clarity on our regulatory path forward and some indication of the potential commercial opportunity in combination treatments.
Our results to date have shown consistent and broad activity all began elicit a crush diverse settings indications and regimens, which we view as highly encouraging.
With our strong execution and growing data foundation, we are now poised to advance again illicit and what we believe our opportunities for success in metastatic <unk> cancer triple negative breast cancer patients.
Given again and <unk> unique mechanism of action.
And consistent signs of activity across trials.
And also see tremendous opportunity to extend beyond those initial indications.
Potentially and PDL, one low patients regardless of tumor type who represent the majority of patients and who are underserved by current therapies.
Before I turn the call over to Larry I would especially like to thank our patients investigators and collaborators at BMS Roche Genentech and August as well as the team at Infinity. Who's continued dedication has enabled our progress with that I turn the call over to Larry.
Eric.
Thank you Brian.
Following our February 'twenty, 'twenty, one public offering and which we raised $92 million of gross proceeds.
At March 31, 2021 and he had total cash cash equivalents.
And available for sales securities of $106 8 million.
Compared to $34 1 million at December 31, 2020.
Research and development expense for the first quarter of 2021 was $8 2 million compared to $7 3 million for the same period and 2020.
This increase was primarily related to clinical and and all the expenses to support the continued development of the catalyst.
General and administrative expenses for the first quarter 2021 was $3 6 million compared to $3 2 million per same period, and 2020, and this increase and G&A expense was primarily due to an increase and stock compensation.
True net loss for the first quarter of 2020, and this was $11 6 million or basic and diluted loss per common share of <unk> 15.
Compared to a net loss of $10 9 million or basic and diluted loss per common share of Nike and the same period and in 2020.
And for these 2021 financial guidance following our February 2020, one public offering.
Is this follows and remains unchanged.
And do you expect net loss for 2021 to range from between 40 and $50 million and at the end of 2021, we expect to have year end cash cash equivalents and available for sale securities balance ranging from between 70 million and $80 million.
Yeah.
We really appreciate your continued support as we move forward with development of a journalist and are very much looking forward to share with you our progress and development of a gantlet.
And at our upcoming July 27th update webcast.
At this time, we can open the call for questions.
Operator.
Thank you ladies and gentlemen, if you have a question at this time. Please press the star and then the number when Keith and I Touchtone telephone again, there'll be side and the number one P of their touchtone telephone. If a question has been answered or you wish to remove yourself from the queue. Please press the husky.
Standby, while we compile the Q&A roster.
Your first question comes from the line of Robyn <unk> from tourists. Your line is now open you may ask your question.
Hi, Thanks for taking my question, so two quick ones. So.
July 27 can you set the standard for how many what kind of update what we get for sure maybe theres, some ambiguity about and Oh.
About how much information, you'll actually gleaned from the FDA ear, but your trial design. So how much first show well, we got around trial design and FDA feedback and how much will be not and second question would be around Europe.
And your data and strategy do you think at that time, you may it be and our position and should give us some clarity around.
T J view of your data and your plan and and how are you thinking about what the best strategic vision would be for your company Inc.
Thanks, Rob and I appreciate the question.
On July 27, and what we are confident that we will be sharing them.
And because it's within our control and we know what patients. We have enrolled is an update on the T and B C data and we're going to have data on at least twice as many patients as we had at San Antonio breast in December and bladder cancer and what we're committed to share an update on our current.
Our outlook for the future development of a gantlet them, but that's going to depend on a couple of different variables that are a little bit outside of our control. One is what decisions. The FDA will make on the accelerated approvals per crude into centric and frontline based on the recent <unk> as well and the status of our current.
And interactions with the FDA So will provide the most recent outlook based on where we're at.
And it'll depend on on those too.
Variables.
And.
With respect to <unk>.
And what the data will mean for our strategy going forward.
Really depends on the quality of the data so we are.
Really looking forward to having data on twice as many T and B C patients there will be as we presented at San Antonio because PD lone low patients or about 60 to 70 per cent of the patient population and as they were and bladder cancer as well we will have more data on the key on the PDL one location. So we want both.
Response rate as well as some durability and particularly on the patients who are already and the 20 patients who are already enrolled at the San Antonio and December.
And.
So depending on what that data looks like as Brian said.
The data will determine are we going to concentrate our efforts going forward on the pier one locations on the tier one high patients on all patients. The data we'll have greatest visibility into in July is the T and B C.
One location.
And then as a follow up I mean, what are your strategic interested and I think they'd probably be bigger and more focus on the broader opportunity and I'm sure. They're watching everything do you have a sense of there one key.
Their focus on from if you're going to go after the broader opportunity and and do a partnership.
Yeah.
Yeah.
So obviously, everyone, who is developing and cancer drugs and looking for better treatments and that's that's certainly true in bladder cancer and breast cancer with respect to what any specific strategic potential partners are looking for and their strategies and attention.
And it's probably better to speak with them directly because we're not going to comment on the status of ongoing discussions.
Great. Thank you.
Thank you Robyn.
Thank you. Your next question comes from the line of Ted Penthouse from Piper Sandler. Your line is now open going to ask a question.
Great. Thank you looking forward to the event on July 27th and I wanted to ask I know, you're also evaluating and catalyst and.
And renal cell carcinoma should we be expecting an update from that cohort as well and is that something we could also get out to 'twenty seven.
Thanks Ted.
Our guidance remains unchanged for renal cell that we will be providing an update on that and the first half of 2020 two.
2022, Okay, great awesome, yeah, great. Thank you and looking towards Yeah go ahead sorry.
Yeah. So that the July 27th update will be primarily focused on the T and B C with a substantial number of additional patients and the current status of our pizza development and bladder yep perfect understood very clear. Thank you.
And that's.
Thank you next question comes from the line of <unk> Rama from Jpmorgan. Your line is now open you may ask your question.
Hey, guys. This is pass out and on the cost and they frown upon thanks for taking our question and.
Sounds good I'm married my own three update and triple negative breast cancer in July and you noted kind of the size of price of patients who should be you should see there, but can you provide a bit more granular on how you think about what a win scenario would be free you guy for that update.
And then a second question would just be when you gave us the update on the pivotal study and you're right.
Cancer and in July as well well you have the FDA minutes and hand, thanks, so much.
Sure. So Brian why don't you start with our thinking about the outlook for data and T and B C. And then I can follow up on the FDA and crashing.
So I think what we do have is we do have for the PDL one positive and the total group and there is very clear benchmarks for what the combination of centric and Abraxa and does.
For the PD Lone low group this clarity on the PFS and the OS, but theres not much clarity on response rate and sort of given a range so and in terms of what I'll be looking at is about 15% above of what you think.
The control group.
Performed and more important the duration of response and the totality of the data in terms of PFS durability. All the other pieces. So I think it would be nice to have a specific number but if you had a response.
And trade a 75% with a duration of four months and it's not really meaningful. So I think you really have to look at that totality of it and the nice thing and June is it will have patients on drug for at least a year.
We will be able to get a feel in terms of those three quick.
Quick question. The response rate the durability of response and how does the whole group.
And then lastly, how the two subsets the PDL, one positive and PD lone negative before but I think the absolute numbers and it's a range for that where PD one high windows, So 59 plus cash.
Cash about 50 keep the same day, so you're not in the high numbers for the PD Lone low the numbers are a little bit all over the map anywhere from 40% to 50%. So we could you could make an argument around that but it's really the totality of the data.
And then on your and your second question about our plans and bladder cancer. If we have completed our discussions with the FDA and we finalize the trial design and we know exactly what that's going to look like we would share that if we haven't yet finalized and discussions and we don't have the final dose.
And what was it was give you an update on when we think we'll have that and what the expected timing for that would be.
Okay, great. Thanks, so much for taking our questions.
Sure. Thank you.
Thank you next question comes from the line of Nick Abbott. The Smells Fargo. Your line is now open you may ask a question.
And good afternoon, and thanks for taking my questions.
And it's just going back to the T and B C study and I think.
And the clinical trial.
And the trial and originally was going to be around 90 patients, but I know the expansion cohorts are triggered and really by the encouraging data.
First one are you still expecting to all around 90 patients and the study.
The weighted average.
Go ahead.
So the plan is to have at least 50, PD lone low patients with <unk> PD Lone high patients.
So at a minimum 60 patients with total study.
But I.
I think it's really going depend a little bit on the data and now.
And how it is also enrolling currently.
For every two PD L. One loans be eroding PD, one PD lone high.
So we might be a little bit shy of one and a little bit more rich and the other.
Okay.
And then just going back pedaling and you're coming on.
At least twice the number of patients per M.
In San Antonio.
Is that and reference to the 13 efficacy eligible patient so the 'twenty total patients.
So.
I'm sorry.
Okay.
So the government and theres going to be.
At least for the a glitch and.
At least two thirds of those will be efficacy and that's the way to think about it.
Correct.
Okay and.
And then just lots and for me I know that you have.
Supporting and that it is.
As Rocco and extend at UCSD.
And neo adjuvant head and neck setting do you have any updates.
Dates and when we might be able to expect some data from that.
So Brian do you want and talk a little bit about that study.
I mean that net.
This study will be a little bit.
It's a little bit dependent on the investigator, but the more data we can get to you.
And as soon as we get that data available, we'll get it out to everybody and it has a lot of translational work bolt in so.
And so that's how much getting the patients on it as much about getting all the translational work done.
But we don't have a firm.
Timeline from Asia as of yet, but obviously you and as soon as we get it available and we will send it to you will get it out okay perfect.
Thank you very much.
Net.
Thank you again, if anyone would like to ask a question you will need to press star and the number one and then a telephone and keep that again that would be star one on your telephone keypad.
Next question, we have the line from Sumit Roy from Jones trading. Your line is now open you may ask a question.
Hi, everyone and thanks for taking the question.
I don't know if you guys ever touched up on the.
And the uncomfortable discrepancy between me and fashion, the one Coty and 131 Curiously you would show us some more debt the details and the date July 27th.
And maybe call mutational status of these patients Brock or.
More biopsy data and steroid usage that kind of flow.
Details on the second question is.
Would you consider a redesigning.
And trial in terms of infection, and 142 like different tricks peso, a chemo combo rather than around Brexit.
Thank you.
So.
The first question, we'd like to share with you as much data and as we can.
That could be that could be the go in terms of the translational data as I mentioned and same thing with interest study is obviously that the translational data sometimes lags behind.
So we will have much less translational data to share with you in terms of other comorbid indications I think if the sample sizes are big enough and the groups are big enough definitely will share with you, but it will really depend on how big the different group saw and we are aware of some of the.
Potential biases that crept into the data for the different studies with the same fix and break so hopefully we can we can review that it will.
We'll be in and uncontrolled settings, so a little bit more.
Difficult to interpret.
In terms of our drive with just the chemo combination we thought about it quite a lot. It makes mechanistic sense based on some of the preclinical models.
But we really have to evaluate the total program.
And.
And just have the data is really good we could easily introduce and all into a study, but right now it's not price.
GAAP forefront of all value of our plans, but a very good and and common thoughts that we have within our group.
Yeah.
Alright, thank you so much.
Thank you at this time and I'm showing no further questions I'd like to turn the call back over to Adam and for closing remarks.
Thank you Mel.
We're very excited to be advancing a tremendous and near term opportunity per analysts said and you know when locations and look forward to meaningful Mario three and triple negative breast cancer data update at our corporate update on July 27th for which details will be forthcoming.
Thank you very much for your continued support and for joining today's call and have a nice evening.
Yeah.
Thank you ladies and gentlemen. This concludes today's conference call you may now disconnect.
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